BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 2043349 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00035
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE EMPTY AND USED PUMP FOR THIS INVESTIGATION. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 100ML AND A FLOW ACCURACY TEST WAS PERFORMED. THE FLOW RATE WAS WITHIN SPEC. RETAINED DEVICES FROM LOT 652573 WERE TESTED FOR FLOW RATE ACCURACY. THE PUMPS WERE FILLED TO A NOMINAL FILL VOLUME OF 100 ML, AND A FLOW ACCURACY TEST WAS PERFORMED. THE FLOW RATE WAS WITHIN SPEC. PRODUCT COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    PUMP EMPTIED TOO FAST (24 HOURS INSTEAD OF 50 HOURS). FILL VOLUME 100 ML AND FLOW RATE 2ML/HR. (DRUG/DILUENT: BUPIVICAINE 0.25%) (PROCEDURE: HERNIA) NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. 5001361 652573

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR